On March 20, CSPC Pharmaceutical Group (1093.HK) announced that its long-acting GLP-1/GIP receptor bipolar agonist polypeptide injection (SYH2082 injection) (hereinafter referred to as "SYH2082") has been approved by the National Medical Products Administration of the People's Republic of China to conduct clinical trials in China. SYH2082 is also expected to be approved by the U.S. Food and Drug Administration (FDA) in February 2026 to conduct clinical trials in the United States.SYH2082 is expected to be a leading-edge long-acting GLP-1/GIP receptor dual-biased agonist in clinical development, requiring monthly dosing. Leveraging the Group's long-acting formulation technology platform, SYH2082 enables monthly dosing, improving patient compliance and ease of use.
SYH2082 selectively activates the cAMP pathway, reducing β-arrestin recruitment, thereby decreasing receptor endocytosis and desensitization, enhancing efficacy, and prolonging the duration of action. Simultaneously, SYH2082 combines long half-life modification platform technology and long-acting formulation platform technology, aiming to achieve sustained weight loss within dosing intervals. In preclinical studies, SYH2082 demonstrated superior efficacy compared to similar marketed products in terms of long-acting weight loss and maintenance, supporting a once-monthly dosing regimen. In toxicology studies, SYH2082 was well-tolerated, with no significant adverse reactions observed.
The approved clinical indication is for weight management in obese or overweight individuals with at least one weight-related comorbidity. Furthermore, SYH2082 also has the potential to improve glycemic control in adults with type 2 diabetes mellitus (T2DM), bringing clinical benefits. This clinical trial approval is a significant achievement in the Group's innovative long-acting product portfolio in the metabolic field, laying a solid foundation for the development of more innovative products in the future.

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